Outcome of the public consultation on the review of Regulation (EC) 1234/2008

Outcome of the public consultation on the review of Regulation (EC) 1234/2008  

 A summary and all contributions received from stakeholders regarding the above mentioned public consultation can be found below.

Total:43 contributions

National authorities (14 contributions):

(1) Belgium FAGG-AFMPS Federal Agency for Medicines and Health Productspdf(13 KB)

(2) Czech Republic Institute for State Control of Veterinary Biologicals and Medicaments pdf(14 KB)

(3) Czech Republic State Institute for Drug Control and Ministry of Health   pdf(174 KB)

(4) Denmark Ministry of Healthpdf(59 KB)

(5) France Agence Nationale du Médicament Vétérinairepdf(906 KB)

(6) Germany BfArM PEI BVLpdf(227 KB)

(7) Hungary Ministry of National Resourcespdf(8 KB)

(8) Italy Ministerio della Salute Dipartimento della Sanità Pubblica Veterinariapdf(38 KB)

(9) Lithuania States Medicines Control Agencypdf(50 KB)

(10) Netherlands Ministry of Economic Affairs, Agriculture and Innovationpdf(16 KB)

(11) Poland The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products pdf(172 KB)

(12) Spain AGEMEDpdf(111 KB)

(13) UK MHRApdf(176 KB)

(14) UK Veterinary Medicines Directorate (VMD)pdf(2 MB)

Industry (24 contributions):

Associations (14 contributions)

(15) AESGP – Association of the European Self-Medication Industrypdf(71 KB)

(16) APIC – Active Pharmaceutical Ingredients Committeepdf(34 KB)

(17) APREFAR – Portuguese Regulatory Professionals Associationpdf(8 KB)

(18) BPI – German Pharmaceutical Industry Associationpdf(94 KB)

(19) EAEPC –  European Association of Euro-Pharmaceutical Companiespdf(956 KB)

(20) ECHAMPpdf(61 KB)

(21) EFPIA – European Federation of Pharmaceutical Industries and Associations, including:pdf(164 KB)

–      EBE - European Biopharmaceutical Enterprises

–      EVM - European Vaccines Manufacturers Association

(22) EGA – European Generic Medicines Associationpdf(151 KB)

(23) EGGVP – European Group for Generic Veterinary Productspdf(154 KB)

(24) EUCOPE  –  European Confederation of Pharmaceutical Entrepreneurspdf(794 KB)

(25) EUROPABIO – European Association for Bioindustriespdf(128 KB)

(26) EVM– European Vaccines Manufacturers Associationpdf(25 KB)

(27) IFAH-Europe – International Federation for Animal Health – Europepdf(90 KB)

(28) IPFA  –  International Plasma Fractionation Associationpdf(99 KB)

Individual companies (10  contributions)

(29) Apotex Europe BVpdf(72 KB)

(30) Bimedapdf(157 KB)

(31) ELC GROUPpdf(26 KB)

(32) Laboratoire du Fractionnement et des Biotechnologies (LFB, S.A.).pdf(157 KB)

(33) Laboratorios Maymó, S.A.pdf(184 KB)

(34) MSDpdf(64 KB)

(35) Mundipharma Research Ltd.pdf(238 KB)

(36) Sanofi-Aventis GmbH Österreichpdf(52 KB)

(37) Stallergenespdf(209 KB)

(38) Weleda AGpdf(9 KB)

Other stakeholders (5 contributions):

(39) CMD(h) – Coordination Group for Mutual Recognition and Decentralised Procedures (human)  pdf(192 KB)

(40) CMD(v) – Coordination Group for Mutual Recognition and Decentralised Procedures (veterinary)  pdf(4 MB)

(41) EMApdf(183 KB)

(42) Nilesh Shethpdf(17 KB)

(43)Prescrire pdf(405 KB)